Clinical trial · Interventional
Carboprost (Hemabate) for Fibroid Resection
Carboprost Tromethamine (Hemabate) for Resection of Fibroids-a Pilot Study
NCT05518812CI-TRIAL-00080747completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research study is to determine if low-dose (i.e., a fraction of what is commonly used) carboprost (Hemabate) helps facilitate fibroid removal (myomectomy).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroid Uterus | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Gynecologic Disease | — | UNRESOLVED | — |
| Leiomyoma, Uterine | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboprost Tromethamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hemabate
- description
- Dilute the 250mcg/mL vial with 25mL saline to create a solution of 10mcg/mL, and inject no more than 10mL of diluted solution at the base of the fibroid. The route of administration depends on the location of the fibroid.
- interventionNames
- Drug: Carboprost Tromethamine
Primary outcomes (1)
- measure
- Does instillation of low-dose carboprost facilitate complete resection of FIGO II fibroids during hysteroscopic resection?
- timeFrame
- Pre-operatively to 1 month post-operatively
- description
- Pre-operative and post-operative ultrasound will be compared to measure the residual fibroid after hysteroscopic resection with carboprost installation.
Secondary outcomes (1)
- measure
- To quantitatively assess the efficiency of fibroid resection after carboprost administration by analyzing the video recording from surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients scheduled to undergo myomectomy with a surgeon in the division of Minimally Invasive Gynecologic Surgery * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * If any oxytocic agents have been or will be administered prior to surgery * History of renal and/or hepatic impairment * Active cardiac disease, pulmonary disease, or pelvic inflammatory disease (PID) * Anemia (Hgb \< 7g/dL), diabetes mellitus, jaundice, or epilepsy
References
Publications (1)
- DERIVEDCromack SC, Yu L, Milad MP. Prostaglandin Injection for Myoma Expulsion (PRIME): Case Series of a Novel Approach to Hysteroscopic Resection of FIGO Type 2 Myomas. J Minim Invasive Gynecol. 2024 Jul;31(7):613-619. doi: 10.1016/j.jmig.2024.03.011. Epub 2024 Apr 10. PMID 38604533